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Studi Osservazionali in corso

10-ott-2023

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Title Multicenter, Nationwide, Observational, Prospective Study Based on the Development of a Primary Sclerosing Cholangitis Patient's Database Linked to a Biological Sample Storage
NCT Number

NCT05618145

PSC_Database

Conditions Primary Sclerosing Cholangitis
Interventions Other: Clinical information
Sponsor/Collaborators University of Milano Bicocca
Gender All
Age 17 Years and older   (Child, Adult, Older Adult)
Phases  
Enrollment 6000 participants
Study Type Observational
Study Designs Cohort
Start Date 21/10/2022
Completion Date 21/10/2032
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastroenterologia, prof.ssa Vincenza Calvaruso
URL https://www.clinicaltrials.gov/ct2/show/NCT05618145 

  

Study Title A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
NCT Number NCT01848561 Other IDs: P11-282
Conditions Ulcerative Colitis (UC)
Interventions  
Sponsor AbbVie
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 8250
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 29/04/2013
Completion Date 24/06/2030
Locations Dott.ssa Maria Cappello, Gastroenterologia , Direttore Prof. Calogero Cammà, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 141397, Palermo, 90127, Italy| A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 141392, Palermo, 90146, Italy|
Study URL https://clinicaltrials.gov/study/NCT01848561 

   

Study Title AutoInflammatory Disease Alliance Registry (AIDA)
NCT Number NCT05200715 Other IDs: AIDA V.04 19.05.2021
Conditions Hereditary Autoinflammatory Diseases|Schnitzler Syndrome|Behcet Syndrome|PFAPA Syndrome|Still Disease|Autoinflammatory Syndrome, Unspecified|Uveitis|Scleritis|Vexas Syndrome
Interventions OTHER: No intervention is foreseen by the protocol.
Sponsor University of Siena
Sex ALL
Age CHILD, ADULT, OLDER_ADULT
Phases  
Enrollment 3500
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 08/06/2020
Completion Date 08/06/2030
Locations ARNAS Ospedale Civico di Cristina Benfratelli, Palermo, Italy| Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy| prof.ssa Maria Cristina Maggio, University Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE) “G. D’Alessandro”, University of Palermo, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT05200715 

 

Study Title National Database on Primary Biliary Cholangitis
NCT Number NCT05151809
Conditions Primary Biliary Cholangitis
Interventions OTHER: Clinical information
Sponsor University of Milano Bicocca
Phases  
Enrollment 6000
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 19/09/2019
Completion Date 24/01/2029
Locations UO gastroenterologia, Policlinico Paolo Giaccone, Palermo, Italy, prof. Calogero Cammà
Study URL https://clinicaltrials.gov/study/NCT05151809 

  

Study Title A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
NCT Number NCT02130362
Other IDs: P11-292
Conditions Crohn's Disease
Interventions  
Sponsor AbbVie
Sex ALL
Age CHILD
Phases  
Enrollment 1446
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 28/08/2014
Completion Date 03/02/2028
Locations U.O. Gastroenterologia - Malattie Infiammatorie Croniche Intestinali, Prof. Calogero Cammà, Policlinico Paolo Giaccone /ID# 138410, Palermo, Sicilia, 90127, Italy|  A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684, Palermo, 90146, Italy|
Study URL https://clinicaltrials.gov/study/NCT02130362 

 

Title Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study
NCT Number NCT05049798
Conditions Intervention/treatment 
Arthritis, Psoriatic
Interventions Drug: Guselkumab
Drug: IL-17i
Sponsor/Collaborators Janssen Pharmaceutica N.V., Belgium
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 1300 participants
Study Type Observational
Study Designs Cohort
Start Date 25/08/2021
Completion Date 07/12/2027
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Dermatologia, Prof.ssa Maria Rita Bongiorno
URL https://www.clinicaltrials.gov/ct2/show/NCT05049798 

 

Title Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
NCT Number NCT04867915
CLL2121
Conditions Chronic Lymphocytic Leukemia
 
Small Lymphocytic Lymphoma
 
MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type
Interventions  
Sponsor/Collaborators Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 12500 participants
Study Type Observational
Study Designs Case-Only
Start Date 13/10/2021
Completion Date 31/10/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04867915 

 

Title Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY): A GIMEMA Observational Registry for Italian MPN Patients
NCT Number NCT04378855
QoL MPN0118
Conditions Myeloproliferative Neoplasm
Other: Questionnaire
Interventions  
Sponsor/Collaborators Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases Phase 2
Enrollment 576 participants
Study Type Observational
Study Designs Cohort
Start Date 30/09/2020
Completion Date 31/10/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04378855 

 

Title Prospective Observational Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
NCT Number NCT05548062
CINC424BIT01
Conditions Intervention/treatment 
Polycythemia Vera
Interventions Other: Hydroxyurea
Other: Ruxolitinib
Sponsor/Collaborators Novartis ( Novartis Pharmaceuticals )
Gender All
Age 18 Years to 99 Years   (Adult, Older Adult)
Phases  
Enrollment 300 participants
Study Type Observational
Study Designs Cohort
Start Date 02/03/2023
Completion Date 30/09/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT05548062 

 

Title Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients
NCT Number NCT05616871
P22-897
Conditions Psoriatic Arthritis
Interventions  
Sponsor/Collaborators AbbVie
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 450 participants
Study Type Observational
Study Designs Cohort
Start Date 15/12/2022
Completion Date 14/06/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo
URL https://www.clinicaltrials.gov/ct2/show/NCT05616871 

 

Title An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® (Avatrombopag) in Adult Patients With Immune Thrombocytopenia (ITP)
NCT Number NCT04943042
Sobi.Doptelet-001
Conditions Intervention/treatment 
Immune Thrombocytopenia
ITP
Interventions Drug: Avatrombopag
Sponsor/Collaborators Swedish Orphan Biovitrum - CRO: Syneos Health Italy S.r.l. 
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 150 participants
Study Type Observational
Study Designs Cohort
Start Date 22/02/2022
Completion Date 01/05/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof.ssa Mariasanta Napolitano, U.O.C. di Ematologia
URL https://www.clinicaltrials.gov/ct2/show/NCT04943042 

 

Title Non-Interventional Study of the Change in Joint Health in Adult Patients With Haemophilia A After Switching to Prophylaxis With Turoctocog Alfa Pegol (N8-GP)
NCT Number NCT05621746
NN7088-4928
Conditions Intervention/treatment 
 
Haemophilia A
 
Drug: Esperoct
Interventions  
Sponsor/Collaborators Novo Nordisk A/S
Gender Male
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 100 participants
Study Type Observational
Study Designs Cohort
Start Date 23/11/2022
Completion Date 14/02/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Ematologia, prof.ssa Mariasanta Napolitano
URL https://www.clinicaltrials.gov/ct2/show/NCT05621746 

 

Title Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy: An Observational Prospective Study Of The Fondazione Italiana Linfomi
NCT Number NCT05524298
FIL_QoL-ELDIND
Conditions Low Grade Non-Hodgkin's Lymphoma, Adult
Interventions  
Sponsor/Collaborators Fondazione Italiana Linfomi ONLUS
Gender All
Age 70 Years and older   (Older Adult)
Phases  
Enrollment 150 participants
Study Type Observational
Study Designs Cohort
Start Date 01/09/2022
Completion Date 01/02/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Dott.ssa Salvatrice Mancuso
URL https://www.clinicaltrials.gov/ct2/show/NCT05524298 

  

Study Title Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
NCT Number NCT04579367
Other IDs: DSE-BMP-01-20-EU
Conditions Hypercholesterolemia|Mixed Dyslipidemia
Interventions DRUG: Bempedoic acid and/or its fixed-dose combination with ezetimibe
Sponsor Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 5000
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: 
Start Date 15/01/2021
Completion Date 09/01/2025
Locations prof. Maurizio Averna, Medicina Interna e Dislipidemie Genetiche, Dir. Prof. Carlo Maria Barbagallo,  A.O.U. Policlinico "P. Giaccone", Palermo, 90127, Italy|  Casa di Cura Triolo Zancla Hospital, Palermo, 90133, Italy|
Study URL https://clinicaltrials.gov/study/NCT04579367 

 

Title The BASA Study: Breath Analysis for Severe Asthma Patients. A New, Non-invasive Approach for the Monitoring of Inflammation in Severe Asthma Patients on Biologics
NCT Number NCT05946421
Conditions Intervention/treatment 
Severe Asthma
Interventions Device: exhaled breath analysis
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 100 participants
Study Type Observational
Study Designs Cohort
Start Date 04/07/2023
Completion Date 04/09/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, Nicola Scichilone, Stefania Principe, Carmen Durante
URL https://www.clinicaltrials.gov/ct2/show/NCT05946421 

 

Title A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS)
NCT Number NCT04460950
AML2120
Conditions Acute Myeloid Leukemia
 
Familial Acute Myeloid Leukemia
 
Myelodysplastic Syndromes
Interventions  
Sponsor/Collaborators Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 237 participants
Study Type Observational
Study Designs Case-Only
Start Date 16/12/2020
Completion Date 31/03/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra
URL https://www.clinicaltrials.gov/ct2/show/NCT04460950 

  

Study Title ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)
NCT Number NCT02078427 Other IDs: 061001
Conditions Hemophilia A
Interventions BIOLOGICAL: ADVATE|BIOLOGICAL: ADYNOVI
Sponsor Baxalta now part of Shire - Collaborators: Baxalta Innovations GmbH, now part of Shire
Sex ALL
Age CHILD, ADULT, OLDER_ADULT
Phases  
Enrollment 955
Study Type OBSERVATIONAL
Study Design Observational Model |Time Perspective
Start Date 29/06/2011
Completion Date 16/01/2024
Locations U.O.C. di Ematologia, Prof. Sergio Siragusa, AOUP P. Giaccone, Palermo, 90133, Italy|
Study URL https://clinicaltrials.gov/study/NCT02078427